Sexual BehaviorNCT03114410
An Evaluation of Re:MIX: a Teen Pregnancy Prevention Program With Young Parents as Peer Educators, EngenderHealth
A study testing Re:MIX, a multi-layer comprehensive teen pregnancy prevention intervention aimed at reducing pregnancy and STIs among youth ages 13-17 in people with Sexual Behavior and Unprotected Sex, run by Child Trends at 1 site in United States.
Trial summary
This study uses a cluster-level randomized controlled design to evaluate the efficacy of Re:MIX in reducing the incidences of early sexual behavior, unprotected sex, oral sex, pregnancy, and STIs. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Sexual Behavior, Unprotected Sex
- What is being tested?
- Re:MIX, a multi-layer comprehensive teen pregnancy prevention intervention aimed at reducing pregnancy and STIs among youth ages 13-17
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 621 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Students in 8-10th grade classrooms in three public charter schools in Travis County, Texas
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
This study uses a cluster-level randomized controlled design to evaluate the efficacy of Re:MIX in reducing the incidences of early sexual behavior, unprotected sex, oral sex, pregnancy, and STIs. Re:MIX is a comprehensive in-school health curriculum and teen pregnancy prevention program for adolescents covering a broad range of topics related to sexual health and youth development, including healthy relationships, communication, gender, consent, reproductive anatomy, contraception, sexual decision making, clinics, parenthood, and life planning. Re:MIX also aims to connect students and peer educators with community resources and service linkages. The Re:MIX curriculum teaches mixed-gender groups of students in grades 8 to 10 to delay sex and use protection if they have sex. A co-facilitation team of young parent educators delivered the information with professional health educators using non-traditional approaches, such as game-based tools, technology, and storytelling. Youth received roughly nine hours and 10 minutes of group sessions during the school day over one semester (55 minutes per week for 10 weeks). Participants were in 8th, 9th, and 10th graders attending three public charter schools in Travis County, Texas. Comparison classes either received an alternative program that focused on health, nutrition, and fitness, or business as usual. This study was conducted as a Rigorous Evaluation of New or Innovative Approaches to Prevent Teen Pregnancy funded by the U.S. Department of Health and Human Services' Office of Adolescent Health.
- Conditions
- Sexual Behavior, Unprotected Sex
- Being tested
- Re:MIX, a multi-layer comprehensive teen pregnancy prevention intervention aimed at reducing pregnancy and STIs among youth ages 13-17
- Medical subject headings
- Sexual Behavior, Unsafe Sex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re:MIX, a multi-layer comprehensive teen pregnancy prevention intervention aimed at reducing pregnancy and STIs among youth ages 13-17Behavioural
Re:MIX is a comprehensive in-school health curriculum and teen pregnancy prevention program for adolescents covering a broad range of topics related to sexual health and youth development, including healthy relationships, communication, gender, consent, reproductive anatomy, contraception, sexual decision making, clinics, parenthood, and life planning. Re:MIX also aims to connect students and young parent educators with community resources and service linkages. The Re:MIX curriculum teaches mixed-gender groups of students in grades 8 to 10 to delay sex and use protection if they have sex. A co-facilitation team of young parent educators delivered the information with professional health educators using non-traditional approaches, such as game-based tools, technology, and storytelling. Youth received roughly nine hours and 10 minutes of group sessions during the school day over one semester (55 minutes per week for 10 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Re:MIX | Experimental | In the experimental arm, the Re:MIX curriculum was implemented. The Re:MIX curriculum is a comprehensive teen pregnancy prevention consisting of ten hour-long sessions, delivered approximately once per week. The Re:MIX curriculum is taught by a professional health educator, partnered with a young parent educator who is a young parent (aged 18-25). Receives: Behavioral: Re:MIX, a multi-layer comprehensive teen pregnancy prevention intervention aimed at reducing pregnancy and STIs among youth ages 13-17 |
| Comparison | No intervention | In the comparison arm, teachers were given the option of implementing the Healthy Youth, Healthy You curriculum (focusing on nutrition, mental health, and fitness) or proceed with "business as usual" (no curriculum). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ever had sexual intercourse
Single dichotomous item on self-report questionnaire.
Measured: 12 months after baseline
Unprotected sexual intercourse in the past 3 months.
Single dichotomous item on self-report questionnaire.
Measured: 12 months after baseline
Secondary outcomes (4)
Intentions
Single dichotomous item on self-report questionnaire measuring intentions to have sex in the next year.
Measured: 3 and 12 months after baseline
Knowledge
Outcome was measured using items on a self-report questionnaire related to knowledge about condoms, STI prevention and birth control efficacy
Measured: 3 and 12 months after baseline
Attitudes
Outcome was measured using items on a self-report questionnaire related to attitudes about gender roles, gender and sexual identities, early sex, condom use, early pregnancy and being a teen parent.
Measured: 3 and 12 months after baseline
Self-efficacy in avoiding unwanted/unprotected sex and communication with partners
Outcome was measured using items on a self-report questionnaire related to self-efficacy in obtaining birth control, negotiating condom use avoiding unwanted sexual contact, asking for, and providing consent and assertive communication.
Measured: 3 and 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study startJul 2016
- Primary completion17 Dec 2019
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 621 participants (actual)
Sponsor and investigators
- Lead sponsor
- Child Trends
- Sponsor type
- University, hospital or other
- Collaborators
- EngenderHealth, University of Texas at Austin, The Office of Adolescent Health, HHS
- Responsible party
- Principal investigator, Jennifer Manlove, Child Trends
- Investigators
- Jennifer Manlove, PhD, Principal investigator, Child Trends, Senior Program Area DirectorMonica Armendariz, Principal investigator, EngenderHealth: Project Director/Co-Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114410
- Sponsor's protocol ID
- TP2AH000033-01-01
- Other IDs
- TP2AH000033-01-01
- Status last verified
- Apr 2020
- First submitted
- 16 Mar 2017
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Re:MIX: a Teen Pregnancy Prevention Program With Young Parents as Peer Educators, EngenderHealth
- ClinicalTrials.gov ID
- NCT03114410
- Acronym / sponsor ID
- TP2AH000033-01-01
- Conditions
- Sexual Behavior, Unprotected Sex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 621 participants (actual)
- Lead sponsor
- Child TrendsUniversity, hospital or other
- Collaborators
- EngenderHealth, University of Texas at Austin, The Office of Adolescent Health, HHS
- Study start
- Jul 2016 (actual)
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study uses a cluster-level randomized controlled design to evaluate the efficacy of Re:MIX in reducing the incidences of early sexual behavior, unprotected sex, oral sex, pregnancy, and STIs. Re:MIX is a comprehensive in-school health curriculum and teen pregnancy prevention program for adolescents covering a broad range of topics related to sexual health and youth development, including healthy relationships, communication, gender, consent, reproductive anatomy, contraception, sexual decision making, clinics, parenthood, and life planning. Re:MIX also aims to connect students and peer educators with community resources and service linkages. The Re:MIX curriculum teaches mixed-gender groups of students in grades 8 to 10 to delay sex and use protection if they have sex. A co-facilitation team of young parent educators delivered the information with professional health educators using non-traditional approaches, such as game-based tools, technology, and storytelling. Youth received roughly nine hours and 10 minutes of group sessions during the school day over one semester (55 minutes per week for 10 weeks). Participants were in 8th, 9th, and 10th graders attending three public charter schools in Travis County, Texas. Comparison classes either received an alternative program that focused on health, nutrition, and fitness, or business as usual. This study was conducted as a Rigorous Evaluation of New or Innovative Approaches to Prevent Teen Pregnancy funded by the U.S. Department of Health and Human Services' Office of Adolescent Health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Re:MIX | Experimental | Behavioral: Re:MIX, a multi-layer comprehensive teen pregnancy prevention intervention aimed at reducing pregnancy and STIs among youth ages 13-17In the experimental arm, the Re:MIX curriculum was implemented. The Re:MIX curriculum is a comprehensive teen pregnancy prevention consisting of ten hour-long sessions, delivered approximately once per week. The Re:MIX curriculum is taught by a professional health educator, partnered with a young parent educator who is a young parent (aged 18-25). |
| Comparison | No intervention | –In the comparison arm, teachers were given the option of implementing the Healthy Youth, Healthy You curriculum (focusing on nutrition, mental health, and fitness) or proceed with "business as usual" (no curriculum). |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Students in 8-10th grade classrooms in three public charter schools in Travis County, Texas
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Re:MIX, a multi-layer comprehensive teen pregnancy prevention intervention aimed at reducing pregnancy and STIs among youth ages 13-17Re:MIX is a comprehensive in-school health curriculum and teen pregnancy prevention program for adolescents covering a broad range of topics related to sexual health and youth development, including healthy relationships, communication, gender, consent, reproductive anatomy, contraception, sexual decision making, clinics, parenthood, and life planning. Re:MIX also aims to connect students and young parent educators with community resources and service linkages. The Re:MIX curriculum teaches mixed-gender groups of students in grades 8 to 10 to delay sex and use protection if they have sex. A co-facilitation team of young parent educators delivered the information with professional health educators using non-traditional approaches, such as game-based tools, technology, and storytelling. Youth received roughly nine hours and 10 minutes of group sessions during the school day over one semester (55 minutes per week for 10 weeks). | Behavioural | Re:MIX |
Primary outcome
Ever had sexual intercourse
Time frame: 12 months after baseline
Single dichotomous item on self-report questionnaire.
Unprotected sexual intercourse in the past 3 months.
Time frame: 12 months after baseline
Single dichotomous item on self-report questionnaire.
4 secondary outcomes
Intentions
Time frame: 3 and 12 months after baseline
Knowledge
Time frame: 3 and 12 months after baseline
Attitudes
Time frame: 3 and 12 months after baseline
Self-efficacy in avoiding unwanted/unprotected sex and communication with partners
Time frame: 3 and 12 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Manlove, PhD principal investigator
Child Trends, Senior Program Area Director
Monica Armendariz principal investigator
EngenderHealth: Project Director/Co-Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Re:MIX, a multi-layer comprehensive teen pregnancy prevention intervention aimed at reducing pregnancy and STIs among youth ages 13-17 in people with Sexual Behavior and Unprotected Sex, run by Child Trends at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ever had sexual intercourse (time frame: 12 months after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2020.